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510(k) K060386

NEXA CARPO METACARPAL IMPLANT by Nexa Orthopedics, Inc. — Product Code KYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2006
Date Received
February 14, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Carpal Trapezium
Device Class
Class II
Regulation Number
888.3770
Review Panel
OR
Submission Type

Other clearances by Nexa Orthopedics, Inc.

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  • K060071 — NEXA COMPRESSION SCREW (January 26, 2006)
  • K053408 — NEXA BONE PLATE AND SCREW SYSTEM (December 22, 2005)
  • K053394 — NEXA BONE SCREW SYSTEM (December 14, 2005)
  • K051740 — TAPERED COMPRESSION PIN (September 6, 2005)
  • K051406 — OSTEOCURE RESORBABLE BEAD KIT (August 1, 2005)
  • K033046 — SUBTALAR PEG IMPLANT (December 23, 2003)
  • K032902 — SUBTALAR ARTHRORISIS IMPLANT (December 15, 2003)

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  • K112278 — ASCENSION NUGRIP CMC IMPLANT (November 4, 2011)
  • K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS (December 15, 2009)
  • K061956 — ARTELON STT SPACER (June 7, 2007)
  • K061954 — ARTELON CMC SPACER ARTHRO (June 1, 2007)
  • K061451 — ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (August 11, 2006)
  • K061089 — MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 1 (June 20, 2006)
  • K052596 — MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17 (November 15, 2005)